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UPDATE ON CERVICAL DISEASE

OBG Management. 2009 March;21(03):46-57
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The author revisits his declaration in the 2006 Update that “we’re on the way to ending cervical cancer.” What’s happened in 3 years with screening, HPV testing, and cancer prevention?

Guillain-Barré syndrome has been reported after vaccination with Gardasil. This rare disorder occurs in 1 or 2 of every 100,000 adolescents, and can be caused by any of several infectious agents. The FDA and CDC report no indication that Gardasil increases the rate of Guillain-Barré syndrome in females above the rate expected in the general population.

Blood clots have been reported in the heart, lungs, and legs of women after vaccination with Gardasil. In most cases, thorough evaluation identified other risk factors for clotting, including use of an oral contraceptive.

Death. There have been 27 reports in the United States of death among females who have been given the vaccine. The FDA-CDC review of each case has not documented a common pattern to these deaths to suggest that the vaccine was the cause of death. Here is a breakdown of those 27 reports:

  • 3 related to diabetes or heart failure
  • 3 to a viral illness, including meningitis
  • 2 to drug use
  • 2 to blood clots
  • 5 are still being evaluated
  • 1 report of a seizure disorder (patient had a history of seizures)
  • 11 reports in which the cause of death is: unknown; cannot be evaluated because the person’s name or the death is unverified; or is still under review while medical records are obtained.
WHAT THIS MEANS FOR PRACTICE
  • Anti-18 antibody detection is not a good marker for determination of efficacy of the HPV vaccine for prevention of lesions caused by HPV 18.
  • To prevent syncope-related injury, the CDC and FDA recommend that you keep patients in a seated position, observed, for 15 minutes after vaccination with Gardasil.
  • Proceed with confidence in administering the HPV vaccine. The FDA-CDC report concludes that “based on all of the information we have today, CDC and FDA have determined that Gardasil is safe to use and effective in preventing 4 types of HPV. The CDC and FDA will continue to monitor the safety of Gardasil.”